03632307

GUDID H981036323070

TROCAR FOR NAVIGABLE CANNULATED AWL/PROBES/TAPS

Synthes GmbH

Orthopaedic trocar blade, reusable
Primary Device IDH981036323070
NIH Device Record Key44a8ff80-8c07-42e2-b1e7-55f661ac3f1a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.632.307
Catalog Number03632307
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034719733 [Primary]
HIBCCH981036323070 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981036323070]

Moist Heat or Steam Sterilization


[H981036323070]

Moist Heat or Steam Sterilization


[H981036323070]

Moist Heat or Steam Sterilization


[H981036323070]

Moist Heat or Steam Sterilization


[H981036323070]

Moist Heat or Steam Sterilization


[H981036323070]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-01
Device Publish Date2016-06-30

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07612334268679 - KINCISE2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE
07612334268563 - KINCISE2024-11-04 KINCISE™ System Automated Surgical Handpiece V2
07612334268570 - KINCISE2024-11-04 KINCISE™ System Lithium-ion Battery
07612334268594 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long
07612334268600 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor
07612334268617 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Inclination Guide

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